Search Results
Found 1 results
510(k) Data Aggregation
(210 days)
Inclusive® Tapered Implant System is indicated for use in maxillary and mandibular partially or fully edentulous cases, to support single, multiple-unit, and overdenture restorations. The implants are to be used for immediate loading only in the presence of primary stability and appropriate occlusal loading.
The proposed device, Inclusive® Tapered Implant System, is manufactured from biocompatible Titanium alloy. The implant is designed with an internal hex connection with a diameter of implant with a 6-point flower (drawings are provided in the table below). Equipped with a tapered body and used to replace one or more missing teeth. The surface is blasted with Hydroxyl Apatite and acid etched. The dental implant (proposed device) will be provided sterile using gamma sterilization. The Inclusive Tapered Implant System, includes abutments in the form of healing abutments, engaging and non-engaging temporary abutments, straight and angled titanium abutments, titanium abutment fixation screws and straight multi-unit abutments.
The provided text is a 510(k) summary for the Inclusive® Tapered Implant System. It describes the device, its indications for use, and a comparison to predicate devices to establish substantial equivalence.
Based on the document, here's an analysis of the acceptance criteria and study information:
1. A table of acceptance criteria and the reported device performance
The document does not explicitly present a table of acceptance criteria with corresponding performance metrics like sensitivity, specificity, or AUC, as would be typical for an AI/algorithm-driven medical device. This is because the device in question is an endosseous dental implant, a physical medical device, not a diagnostic algorithm.
Instead, the "acceptance criteria" are implied by adherence to recognized standards and successful completion of non-clinical performance tests for mechanical integrity and biocompatibility. The "reported device performance" is the conclusion that the device meets these standards and functions equivalently to predicate devices.
Here's a table summarizing the performance evaluation strategy:
| Evaluation Aspect | Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|---|
| Biocompatibility | Compliance with ISO 10993-1 or justification through equivalent materials, manufacturing, and patient contact to previously cleared predicate devices. | The device is manufactured from biocompatible Titanium Grade 23 (Ti-6AL-4V ELI) and meets ASTM F-136 Standard. Biocompatibility is justified by equivalence to primary predicate (K121406) and reference predicate (K143353) which use identical materials, same manufacturing process, and same type/duration of patient contact. |
| Mechanical Strength | Dynamic fatigue testing and static load failure testing of finished assembled implant/abutment systems, performed in accordance with FDA Guidance "Class II Special Controls Guidance Document: Root-form Endosseous Dental Implants and Endosseous Dental Implant Abutments" and ISO 14801:2007. | Performance testing (Fatigue Testing and Static Load Failure Testing) was performed and demonstrated implant-to-abutment compatibility. The testing was performed in accordance with the specified FDA Guidance and ISO 14801:2007. The conclusion is that the device has the "same performance specifications" as the predicate devices. |
| Sterility | Adherence to relevant sterilization standards (ANSI-AAMI ST79, ISO 17665-1, ISO 11137-1, ISO 11137-2). | The sterilization and shelf life of all device components are supported by prior validation conducted for the applicant's own primary and reference predicate devices (K121406 and K143353). |
| Design/Materials | Device materials, design, and indications for use must be substantially equivalent to legally marketed predicate devices. | Comparison table (Table 1) demonstrates that the proposed device is "essentially the same as currently marketed devices for the same indications for use, same materials, same fundamental scientific technology and design." Any differences do not introduce new safety/efficacy concerns. |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
This information is not applicable in the context of this 510(k) submission for a physical dental implant. The "test set" here refers to the physical samples of the device and its components used for non-clinical (laboratory) testing, not a dataset for an algorithm.
- Sample Size: The document does not specify the exact number of implants or abutments tested in the fatigue and static load failure tests. It refers to "finished assembled implant/abutment systems" being tested.
- Data Provenance: The data is generated from laboratory testing of the manufactured devices, not from patient data. Therefore, concepts like "country of origin of the data" or "retrospective/prospective" studies do not apply in this context.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
This is not applicable. "Ground truth" in the context of this device refers to the physical properties and performance characteristics of the implant, which are established through standardized engineering and material science tests, not through expert human interpretation or consensus. The tests themselves (e.g., fatigue testing, material composition analysis) provide objective data.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This is not applicable. Adjudication methods like "2+1" or "3+1" are used in studies where human interpretations of data (e.g., medical images) need to be reconciled to establish a ground truth. For mechanical and material testing of a physical device, the results are derived from standardized test procedures and measurements, not human consensus on interpretation.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
This is not applicable. The device is a physical dental implant, not an AI or algorithm. Therefore, an MRMC study related to AI assistance for human readers is irrelevant.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This is not applicable, as the device is a physical dental implant, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
For this physical device, the "ground truth" for demonstrating performance and safety is established through:
- Adherence to recognized standards: E.g., ISO 10993-1 (biocompatibility), ASTM F136 (material properties), ISO 14801 (dynamic fatigue).
- Non-clinical (laboratory) performance testing: Mechanical strength (fatigue and static load failure testing).
- Material verification: Titanium Grade 23 (Ti-6AL-4V ELI) meeting ASTM F-136.
- Sterilization validation: Conformance to ISO and AAMI standards.
These are objective, measurable criteria verified through specific test protocols, rather than subjective expert consensus or clinical outcomes data.
8. The sample size for the training set
This is not applicable. There is no "training set" as this is not an AI/machine learning device.
9. How the ground truth for the training set was established
This is not applicable, as there is no "training set."
Ask a specific question about this device
Page 1 of 1